重度哮喘中替泽利尤单抗随时间推移加重减少幅度增加：CROSSROADS-4

文献信息

中文摘要

背景： 替泽利尤单抗是一种在美国获批用于重度哮喘的单克隆抗体。其真实世界有效性证据仍然有限。
目的： 评估替泽利尤单抗在美国降低年化哮喘加重率（AAERs）和医疗资源利用（HRU）的有效性。
方法： 这项回顾性、自身对照、前后队列研究使用了Symphony Health（ICON plc旗下公司）PatientSource®的数据，时间为2020年12月1日至2024年6月30日。符合条件的患者为≥12岁、有≥2条替泽利尤单抗记录，且在替泽利尤单抗开始前12个月内经历≥2次哮喘加重，索引日期为开始用药后的次日。比较索引前12个月与索引后12个月的AAERs及哮喘加重相关HRU。AAERs还在各患者亚组中进行了评估。
结果： 共纳入527例患者。AAERs从每人年2.81显著降至1.26（下降55%；95%置信区间[CI][51%，59%]；p<0.001）。在2023年2月及以后开始治疗的患者中观察到最大获益（下降61%；[53%-67%]；p<0.001）。各亚组均见一致下降：索引前血嗜酸性粒细胞计数<300个细胞/μL和≥300个细胞/μL的患者、索引前血清总免疫球蛋白E水平<100 IU/mL和≥100 IU/mL的患者、生物制剂初治和生物制剂经治患者、替泽利尤单抗持续使用者，以及合并慢性阻塞性肺疾病或伴鼻息肉的慢性鼻窦炎的患者。哮喘加重相关HRU显著下降（p<0.001），各医疗场所下降50-54%。
结论： 在这项真实世界研究中，接受替泽利尤单抗治疗的重度哮喘患者哮喘加重和HRU大幅减少，近期开始治疗者的获益最大。

英文摘要

BACKGROUND: Tezepelumab is a monoclonal antibody approved in the United States for severe asthma. Real-world evidence of effectiveness remains limited.
OBJECTIVE: To evaluate the effectiveness of tezepelumab in reducing annualized asthma exacerbation rates (AAERs) and healthcare resource utilization (HRU) in the United States.
METHODS: This retrospective, self-controlled, pre-post cohort study used data from Symphony Health, an ICON plc Company, PatientSource®, December 1, 2020, to June 30, 2024. Eligible patients were ≥12 years, had ≥2 records of tezepelumab, and experienced ≥2 asthma exacerbations in the 12 months before tezepelumab initiation, with index date being the day after initiation. AAERs and asthma exacerbation-related HRU were compared between the 12 months pre- and post-index. AAERs were also evaluated across patient subgroups.
RESULTS: A total of 527 patients were included. AAERs decreased significantly from 2.81 to 1.26 per person-year (55% decrease; 95% confidence interval [CI] [51%, 59%]; p<0.001). The greatest benefit was observed among patients starting treatment February 2023 and later (61% decrease; [53%-67%]; p<0.001). Consistent reductions were seen across subgroups: patients with pre-index blood eosinophil count <300 cells/μL and ≥300 cells/μL, pre-index total serum immunoglobulin E levels <100 IU/mL and ≥100 IU/mL, biologic-naïve and biologic-experienced, persistent tezepelumab users, and those with comorbid chronic obstructive pulmonary disease or chronic rhinosinusitis with nasal polyposis. Asthma exacerbation-related HRU declined significantly (p<0.001) with 50-54% reductions across healthcare settings.
CONCLUSIONS: In this real-world study, patients with severe asthma treated with tezepelumab had substantial reductions in asthma exacerbations and HRU, with the greatest benefits among more recent initiators.